Microbiome Sampling During Endurance Exercise

Last updated: March 25, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Microbiome Capsule

Treadmill Exercise

Cooling Gloves

Clinical Study ID

NCT06903806
IRB-67010
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The small intestine and feces of subjects undergoing endurance exercise will be sampled to examine their microbiome composition

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

  • Males or females 18 years of age or older and 70 years of age or younger at the timeof the first Screening Visit.

  • ASA Classifications 1 and 2.

  • For women of childbearing potential, negative urine pregnancy test within 7 days ofScreening Visit. Willingness to use highly effective contraception during the entirestudy period (e.g.: implants, injectables, oral contraceptives, intra-uterine deviceor declared abstinence).

  • Subject is fluent in English and understands the study protocol and informed consentand is willing and able to comply with study requirements and sign the informedconsent form. Non-English speakers will not be included in the study because consentforms are in English, and any instructions during exercise will need to be providedin English.

Exclusion

Exclusion Criteria:

Subjects with any of the following conditions or characteristics must be excluded from the study:

  • History of any of the following:

  • Prior gastric or esophageal surgery, including lap banding or bariatric surgery

  • Bowel obstruction

  • Gastric outlet obstruction

  • Diverticulitis

  • Inflammatory bowel disease

  • Ileostomy or colostomy

  • Gastric or esophageal cancer

  • Achalasia

  • Esophageal diverticulum

  • Active Dysphagia or Odynophagia

  • Active medication use for any gastrointestinal conditions

  • Pregnancy or planned pregnancy within 30 days from Screening Visit, orbreast-feeding

  • Any form of active substance abuse or dependence (including drug or alcohol abuse),unstable medical or psychiatric disorder, or any chronic condition susceptible, inthe opinion of the investigator, to interfere with the conduct of the study

  • A clinical condition that, in the judgment of the investigator, could potentiallypose a health risk to the subject while involved in the study

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: Microbiome Capsule
Phase:
Study Start date:
August 04, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The close relationship between humans and the commensal microbes of their gut microbiota represents vast potential for health maintenance, but most efforts have been focused on disease. Gastrointestinal (GI) problems are very common especially in endurance athletes, and are known to impair performance or subsequent recovery. Moreover, GI symptoms among athletes vary enormously, and some athletes are more prone than others; the links between this variation and the differences in microbiome composition across individuals have not been elucidated. The investigators propose to use a novel, non-invasive sampling technology to quantify the effects of exercise on the GI environment including the small intestines, and aim to establish the potential for dietary interventions to improve recovery from exercise.

Connect with a study center

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.